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Phenytoin sodium powder injection and preparation method thereof

A technology of sodium phenytoin and powder injection, which is applied in the field of preparation of the powder injection, can solve problems such as difficulty in observing the clarity of intravenous drip infusion, difficulty in draining air bubbles, and turbidity of the solution, so as to increase drug safety and reduce irritation , the effect of increased clarity

Inactive Publication Date: 2008-01-16
SHANGHAI NEW ASIA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, there are some problems in the above two injection forms: one, phenytoin can gradually absorb carbon dioxide in the air and decompose into phenytoin, and its aqueous solution often becomes turbid due to partial hydrolysis, especially in the intravenous drip process, it can also block the needle
2. When phenytoin sodium carbonate powder injection is diluted into various rehydration fluids, the carbon dioxide bubbles generated will not only decompose phenytoin sodium and cause turbidity, but also the bubbles are not easy to drain, which brings difficulties to the observation of the clarity of intravenous drip infusion.
3. The pH of phenytoin anhydrous sodium carbonate powder injection is high, ranging from 9.5 to 11.5, which is highly irritating to the injection site and increases the pain of the patient
4. Even if the phenytoin injection uses alcohol as a solvent, when the injection is injected into the blood, it will be unstable and produce phenytoin crystals, reducing its safety
However, after dissolving the monohydrate in water, phenytoin sodium will also convert into phenytoin due to the absorption of carbon dioxide to form insoluble matter, resulting in turbidity or precipitation of the solution
In addition, so far, there is no invention related to the improvement of phenytoin sodium powder injection technology

Method used

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  • Phenytoin sodium powder injection and preparation method thereof
  • Phenytoin sodium powder injection and preparation method thereof
  • Phenytoin sodium powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] A phenytoin sodium powder injection, the phenytoin sodium powder injection is composed of active ingredient phenytoin sodium and cosolvent arginine. in:

[0036] Phenytoin Sodium 0.1g

[0037] Arginine 0.26g

[0038] In this embodiment, the arginine is L-arginine or R-arginine.

[0039] The phenytoin sodium powder injection in the present embodiment adopts following steps to prepare:

[0040] 1. Take 0.1g of phenytoin sodium sterile powder and 0.26g of aseptically processed arginine through a 65 mesh sieve;

[0041] 2. Divide 0.1g of phenytoin sterile powder and 0.26g of arginine into sterilized vials, immediately stopper them and seal them with aluminum-plastic caps.

Embodiment 2

[0043] In this example

[0044] Phenytoin Sodium 1000g

[0045] Arginine 2600g

[0046] Others are the same as in Example 1.

[0047] The phenytoin sodium powder injection in this example is prepared using the following steps: 1. Take 1000g of phenytoin sodium sterile powder passing through a 65 mesh sieve and 2600g of aseptically treated arginine passing through a 65 mesh sieve, and put them in SYH-15 Mix evenly in a three-dimensional motion mixer under vacuum conditions; 2. After the uniformity of the sampling inspection is qualified, the mixed powder is divided into 10,000 sterilized vials with a loading capacity of 0.36±0.025g, and the stopper is immediately used and aluminum The plastic cap is sealed. Tested according to the requirements of the Pharmacopoeia, the clarity is qualified.

Embodiment 3

[0049] In this example,

[0050] Phenytoin Sodium 0.25g

[0051]Arginine 0.65g

[0052] Others are the same as in Example 1.

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Abstract

The invention discloses phenytoin sodium powder injection and the preparation method, relating to power injection for treating falling sickness and relating to the preparation method of the power injection. The invention is characterized in that the phenytoin sodium powder injection contains an active ingredient phenytoin and latent solvent arginine; the arginine is L-arginine or R-arginine. The phenytoin sodium powder injection in the invention, with the arginine as the latent solvent has the advantages that the dissolution is very quick; the clarity is obviously increased; no side effects are produced to patients so that the security of the injection use is increased; the lower pH than the original phenytoin sodium carbonate powder injection helps reduce thrill to the injection site and reduce pain for patients; the concentration of sodions are reduced, therefore the injection can be used to the patient who is limited to absorb sodions.

Description

technical field [0001] The phenytoin sodium powder injection and the preparation method thereof of the present invention relate to a powder injection for treating epilepsy, and also relate to a preparation method of the powder injection. Background technique [0002] Phenytoin Sodium (Phenytoin Sodium), chemical name 5,5-biphenyl-2,4-imidazolinone, structural formula as follows, is a well-known antiepileptic drug and antiarrhythmic drug. It is widely used in the treatment of generalized tonic-twin seizures, complex partial seizures (psychomotor seizures, temporal lobe epilepsy), simple partial seizures (localized seizures) and status epilepticus; it can also be used to treat trigeminal neuralgia, hidden Dystrophic epidermolysis bullosa, episodic choreoathetosis, episodic control disorders (behavioral disorders including rage, anxiety, and hyperexcitability such as insomnia), myotonia, intractable hiccups, and wound healing Wait. This product is also suitable for ventricula...

Claims

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Application Information

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IPC IPC(8): A61K31/4166A61K9/14A61K47/16A61P25/08
Inventor 管海英郑玉林王丽彬李建文
Owner SHANGHAI NEW ASIA PHARMA
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